MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ATTUNE SOLO PINNING SYSTEM; FIXATION PINS

Catalog Number	254400111
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that one of the pin holes did not fit the attune pins.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : according to the information received, ¿it seemed that one of the pin holes did not fit the attune pins.The psi block was decontaminated.¿ the product was not returned to depuy synthes, however photos were provided for review.See attachment (b)(4).The photo investigation revealed that the attune solo pinning system are not able to pass though the guide bushings.The reported issue was most likely caused by the burrs identified on the metal bushings of the guide (trumatch ct cut guide kit r).This trumatch ct cut guide kit r issue is already being addressed by depuy synthes quality system.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the attune solo pinning system would contribute to the complained device issue.Based on the investigation findings, a potential cause cannot be established and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 254400111.Lot # m1114d.Date of manufacture: 9/20/2022.Quantity manufactured:(b)(4).Expiry date: 8/31/2024.No ncrs were generated during production.Device history review : review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Part # 254400111.Lot # m1114d.Date of manufacture: 9/20/2022.Quantity manufactured: (b)(4).Expiry date: 8/31/2024.No ncrs were generated during production.

• Brand Name: ATTUNE SOLO PINNING SYSTEM
• Common Device Name: FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17469171
• Report Number: 1818910-2023-16096
• Device Sequence Number: 20323985
• Product Code: LXH
• UDI-Device Identifier: 10603295129943
• UDI-Public: 10603295129943
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: 254400111
• Device Lot Number: M1114D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown